Purpose.This
funding opportunity announcement (FOA) is being issued by the National
Heart, Lung, and Blood Institute, with participation from the National
Cancer Institute, the National Institute of Diabetes and Digestive and
Kidney Diseases, and the Office of Behavioral and Social Sciences
Research. This FOA solicits cooperative agreement (U01) applications from
institutions/organizations that propose to translate findings from basic research on human
behavior into more effective clinical, community, and population
interventions to reduce obesity and improve obesity-related
behaviors. This FOA will support Centers for Behavioral Intervention
Development (CBIDs) in which interdisciplinary
teams of basic and applied behavioral and social science researchers develop
and refine novel interventions based on basic research findings to reduce obesity and
alter obesity-related health behaviors (e.g., diet, physical activity).

Funds Available and Anticipated Number of Awards.NHLBI intends to commit up to
$25 million (total costs) over five years; NCI intends to commit up to $5
million (total costs) over five years; NIDDK intends to commit up to
$3,750,000 (total costs) over five years; and OBSSR intends to commit up
to $1 million (total costs) over five years. NHLBI anticipates that they
will award up to $5 million in total costs in FY 2009 to fund four to six
applications in response to this FOA; NCI anticipates that they will award
up to $1 million in total costs in FY 2009 to fund one application; NIDDK
anticipates that they will award up to $750,000 in total costs in FY 2009
or 2010 to fund one application; and OBSSR anticipates that they will
award up to $200,000 in total costs in 2009 to cofund one application. Of
these awards, one will serve additionally as a Resource and Coordination
Unit (RCU) to facilitate cross-study activities, such as identifying
common measures, and to coordinate meetings. Awards issued under
this FOA are contingent upon the availability of funds and the submission
of a sufficient number of meritorious applications.

Budget and Project Period.Budgets for direct
costs of up to $3,750,000 may be requested for a project duration of up to
five years. The maximum award for the research component will be
approximately $3,750,000 in direct costs across five years, with a limit
of $750,000 in direct cost for any single year. It is anticipated that the
maximum award for the RCU will be approximately $1,000,000 in direct costs
across five years. The RCU costs are in addition to the research
component costs.

Eligible Project Directors/Principal Investigators (PDs/PIs).Individuals with
the skills, knowledge, and resources necessary to carry out the proposed
research are invited to work with their institution/organization to
develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are
always encouraged to apply for NIH support.

Number of PDs/PIs.More than one PD/PI (i.e., multiple PDs/PIs), may be
designated on the application.

Number of Applications. Applicants may submit more
than one application, provided they are scientifically distinct.

Resubmissions.Resubmission applications are not permitted in response
to this FOA.

Renewals.Renewal applications are not
permitted in response to this FOA.

This FOA solicits cooperative agreement (U01)
applications from institutions/organizations that propose to translate findings from basic
research on human behavior into more effective clinical, community, and
population interventions to reduce obesity and improve obesity-related
behaviors. This FOA will support Centers for Behavioral Intervention
Development (CBIDs) in which interdisciplinary teams
of basic and applied behavioral and social science researchers develop
and refine novel interventions to reduce obesity and alter obesity-related
health behaviors (e.g., diet, physical activity).

The
interventions to be developed include any of a wide range of strategies aimed
at promoting weight loss and/or preventing weight
gain. Interventions can be targeted to the individual, family,
social network, community, environmental, clinical or population level, or
combinations of these, and to any age group.
Investigators at each CBID will conduct several types of studies during
the funding period, including laboratory experimental studies, formative
research, early phase trials and pilot/feasibility studies, in order to
create promising new avenues for reducing obesity and improving obesity-related
behaviors. Because the emphasis is on accelerating the translation of
discoveries in basic biological, behavioral and social science research to
facilitate the prevention and treatment of obesity, this FOA seeks to fund
research aimed at developing, characterizing and refining new, innovative
obesity-reducing strategies rather than evaluating the effectiveness of already
well-defined or proven strategies. At the end of the period of support,
the strategies that have been developed should be wellcharacterized and demonstrated to
be safe, feasible to implement, effective in small-scale trials, acceptable to
the target populations of interest, and ready to be tested in large-scale
randomized clinical and
community trials.

Background

Behaviors such as smoking, sedentary
lifestyles, unhealthy diets, and poor adherence to medical and behavioral
treatments are major contributors to cardiovascular disease, cancer, type 2
diabetes and other chronic conditions. The most
sophisticated advances in prevention and treatment are dependent on individual
behaviors. For example, individuals must recognize, correctly interpret
and act on symptoms of heart disease to be treated, and patients must
participate in all aspects of care in order to derive its
benefits. In particular, the rapid rise in obesity over the past
several decades threatens to reverse recent gains in life expectancy.
Adopting and maintaining healthful dietary habits and a physically active
lifestyle remain fundamental to preventing and treating obesity.

Randomized
controlled trials such as the Trials of Hypertension Prevention, Weight Loss Maintenance, PREMIER,
the Women’s Health Initiative dietary trial, and the Diabetes Prevention
Program have shown that behavioral interventions can improve dietary patterns
and physical activity levels, reduce body weight, lower blood pressure, reduce
LDL levels, and prevent the onset of diabetes. However, even the most
successful behavior change interventions are limited in their ability to induce
long-term behavioral changes in most people. Often change occurs only for
the highly motivated and is limited to a single health behavior rather than
multiple behaviors. Only 3 percent of the U.S. adult population have adopted all of the
multiple behavioral components (nonsmoking, healthy weight, achieving
recommended diet and physical activity goals) that characterize a heart-healthy
lifestyle and that are associated with low rates of cardiovascular
events. Even individuals committed to making behavioral changes find it
hard to maintain a healthy lifestyle over time. Most weight loss studies
show that after six months, participants begin to gain back lost weight, with
most people regaining all of the weight lost by five years.

As with
development of more effective drugs, surgical techniques and medical devices,
the development of better behavioral interventions for preventing and treating
obesity depends on improving our understanding of human behavior, and then
translating that knowledge into interventions. This FOA seeks to promote
an intervention development process for the behavioral and social sciences that
are analogous to Type I translation in the biomedical sciences with the
ultimate goal of achieving greater effectiveness for obesity-related behavior
change strategies.

Translational
research is
“the process of applying ideas, insights, and discoveries generated through
basic scientific inquiry to the treatment or prevention of human
disease”. Translational research consists of two stages: Translation
I (T1), in which basic science discoveries are used to develop new
treatments for disease (“bench to bedside”); and Translation II (T2), which is aimed at improving utilization of proven therapies in clinical
practice and community
settings (“bedside to public health”).

Translation
I research (treatment development) includes the conduct of small human trials
or series (Phase I & II clinical trials) in which data on the safety of the
drug and the dosages needed to obtain effects on biomarkers of the disease
being studied are collected. In Phase I safety studies, the purpose is to
gather information on which dosages are welltolerated by patients with minimal
toxicity; in Phase II studies, the goal is to test for and characterize effects
of the treatment, for example, to determine the amounts of treatment needed to
produce biologic responses, such as reduction in the size of a tumor or lesion.
If the treatment is found to be safe and effective in these early phase
studies, large-scale randomized clinical trials or RCTs (Phase III studies) are
then conducted to test the effects of the treatments developed on health
outcomes such as blood pressure, lipid levels, morbidity or mortality. Often, prior to
instituting a full-scale RCT, a pilot or feasibility study is conducted in the
population and setting of interest in order to assess feasibility and
acceptance of the approach used, refine intervention and measurement
procedures, gain experience in and information concerning screening,
recruitment and retention of the target population (e.g., estimates of yield,
pre-testing of screening/recruitment procedures), and determine estimates of
variability and levels of response in the target population.

The translation process is most often
thought of in the context of biomedical research but it can also be applied to
the development
of behavioral treatments or interventions. For example, one can think about
Translation I or intervention development research in the behavioral and social
sciences as a phased approach aimed at determining the safety profile of a treatment, the “dosages” required (i.e., intensity, frequency, duration
of intervention) to effect change in the intermediate outcomes of interest that
are related to the health condition under study, whether and how a treatment
works in specific patient groups under well-specified conditions, and the feasibility and
acceptance of the intervention in the target population, culminating
in Phase III trials that test the intervention in a large-enough sample of
patients to determine its effects on health outcomes.

Basic
behavioral and social science research is concerned with uncovering the fundamental
principles & processes which govern how human beings perceive the
environment, process information, make decisions, experience, express and
regulate emotion, form and change attitudes, beliefs and values, and become and
remain motivated to change behavior. As defined by the NIH’s Office of
Behavioral and Social Sciences Research (OBSSR), basic
behavioral and social science research can involve research at the individual,
small group, institution, organization, and community or population
level. At the individual level, this research may involve the study of
behavioral factors such as cognition, memory, language, perception,
personality, emotion, motivation, and others. At higher levels of
aggregation, it includes the study of social variables such as the structure
and dynamics of small groups (e.g., couples, families, work groups, etc.); institutions and
organizations (e.g., schools, religious organizations, etc.); communities (defined by geography or
common interest); and larger environmental, demographic, political, economic,
and cultural systems.

Basic
behavioral and social science research may also involve biopsychosocial or
biobehavioral research, which concerns the study of the interactions of
biological factors with behavioral or social variables and how they affect each
other (i.e., the study of bi-directional multilevel relationships).
Additional details and examples of basic behavioral and social science research
can be found on the OBSSR website at http://obssr.od.nih.gov/Content/About_OBSSR/BSSR_Definition/.

Significant
advances in basic behavioral and social science research are contributing to a
more sophisticated understanding of the fundamental biological, cognitive,
emotional, and social underpinnings of human behavior. Recent discoveries
in fields such as cognitive and affective neuroscience, communication science
and social marketing, decision-making, food choice and the formation of habits,
the psychophysiology of stress and eating behavior, behavioral economics, and
the nature and impact of social networks, coupled with the development of more
sophisticated tools for understanding psychosocial determinants and physiologic
concomitants of human behavior (e.g., brain imaging, systems dynamics theories, geospatial
methods), are yielding new and important insights about human cognition,
affect, motivation and behavior. These findings suggest promising new
directions for developing interventions to reduce obesity and promote the
public health.

For
example, animal and human studies have shown that stress increases the salience
and ingestion of highly palatable foods, and in combination with a high-calorie
diet, triggers signaling pathways that promote abdominal fat deposits.
The prefrontal cortex has been implicated in the cognitive control of food
intake and activity levels, possibly through influences on decision-making, perceptions of
body image, and motor planning and execution. Recent research suggests
that many of the neural and hormonal influences on obesity-related behaviors
may be modified by genetic makeup. For example, studies have shown that
without leptin, even unpalatable foods can become desired in the satiated
state, and that genetics influence taste variation, which may have a large
impact on food selection behavior. In addition, there are genetic
influences on ad lib running behavior in animal models and on non-exercise
energy expenditure, as well as candidate genes for sedentariness.
Clearly, research concerning neural, hormonal and genetic influences on obesity
has relevance for the design of weight control interventions, yet little research
is being done to channel these findings into weight loss programs.

Advances have also been made in understanding the influences
of social, economic, geographic and environmental factors on physical activity
and diet. For example, research has suggested that social networks may
play a role in promoting obesity. Data from the Framingham Heart Study
revealed a strong propensity for the spread of obesity within social
groups. This finding suggests the intriguing possibility that social
networks, which can promote unhealthy, obesigenic behaviors, might also be used
to promote healthy lifestyles. Studies using GIS and census data have
also demonstrated that features of the built environment (access to
recreational facilities or grocery stores that stock healthy and affordable
food options) interact in complex ways with other factors (ethnicity,
socioeconomic status) to influence obesity. Can these findings, together
with data from disciplines that seek to better understand the interaction of
individuals and their environments (e.g., environmental cognition, human
ecology, urban planning, and human factors/ergonomics) be used to build
obesity-reducing as opposed to obesity-promoting environments?

The potential for translational behavioral science
research is wellillustrated
by breakthroughs in related fields, such as mental health and drug and alcohol
abuse. A striking example is the discovery of the synergistic effects of
an antibiotic, D-cycloserine (DCS), originally developed to treat tuberculosis,
and cognitive behavior therapy (CBT) for treating anxiety disorders.
Animal studies had shown that DCS is an agonist of the glutamatergic
N-methyl-D-aspartate (NMDA) receptor that operates at the level of the amygdala
and prefrontal cortex to mediate learning, memory and the extinction of conditioned
fear responses. Other animal and human studies showed that DCS promotes
the extinction of fear when administered prior to fear exposure.
Based on these findings, randomized clinical trials demonstrated that DCS, when
administered with CBT but not alone, greatly increased success rates for
treating anxiety disorders. The breakthrough established a new paradigm
for treating other anxiety and fear-based conditions, such as post-traumatic
stress disorder.

This new
approach to treatment would not have been possible without basic behavioral
research in learning, memory, extinction and the emotions, and its integration
with behavioral neuroscience, and illustrates the advances that can be made
when basic science findings are used to generate innovative approaches to
treating challenging behavioral problems, such as obesity. This FOA seeks
to fund systematic collaborations between basic and applied biological,
behavioral and social scientists from diverse disciplines and in doing so, to
encourage the kind of high-risk, potentially high-impact research needed to
develop innovative new strategies for reducing obesity and improving
obesity-related behaviors.

Objectives and Scope

The purpose of this FOA is to fund up
to eight Centers for Behavioral Intervention Development (CBID). Each
CBID will support interdisciplinary project teams that include basic and
applied biological, clinical, behavioral and social scientists who will adapt
findings from basic behavioral and social science research to develop behavioral
interventions aimed at improving obesity-related behaviors. The
interventions to be developed will be based on basic behavioral and social
science research findings from studies of individuals (e.g., studies of
cognition, memory, language, perception, attitude formation and change, emotion
regulation, motivation); social groups (e.g., research on the structure and
dynamics of small groups such as couples and families, or social networks);
institutions and organizations (e.g., worksites, schools, health care systems);
and/or demographic, economic, environmental and cultural systems that have a
significant role in obesity-related behaviors of interest. The proposed
interventions may target any one or more of these levels (i.e., individuals,
social groups, institutions/ organizations, environments or systems), and any
age group. Populations of interest include healthy individuals, those at
high risk for a particular disease or condition, and those with an existing
disease (e.g., cardiovascular disease, cancer or diabetes).

Behavioral targets of the interventions
being developed may be any one or more of the behaviors thought to be important
for the treatment or prevention of obesity, including, but not limited to,
energy intake, physical activity, sedentary lifestyle, and adherence to
specific behavioral strategies used in weight control programs (e.g.,
self-monitoring of eating and physical activity levels). Broader social,
organizational or systems level interventions that involve changing aspects of
the social environment (behavior of individuals within social networks),
cultural environment (norms or values of worksites or schools) and/or physical
environments (features of neighborhoods) may use aggregate measures of behavior
as outcomes (e.g., use of walking and bike paths, purchases of fruits and
vegetables or other healthy foods).

The behavioral target(s) of the
intervention should be well-specified and precisely defined. For example,
the distinction between sedentariness and physically active lifestyle is
important as these two behaviors may not represent opposite points along the
same continuum, and both are known to contribute to obesity. This type of
distinction has important implications for how basic behavioral research is
used to inform translational efforts, since basic research may inform
intervention development in different ways depending upon whether the target of
the intervention is promoting physical activity versus preventing or reducing
sedentary behavior (e.g., strategies that involve motivation, affective
response, reinforcement and incentivizing behavior may be structured
differently when the goal is to reduce sedentary behavior rather than to
promote physical activity). Similarly, different intervention strategies may
be more effective when the behavioral target involves initial adoption of a
dietary or physical activity behavior than when the goal is maintenance of the
behavior over time.

Depending
on the types of interventions being developed, it is expected that CBIDs will
need to conduct several types of studies to translate basic science findings
into behavioral interventions, including: (1) experimental studies of
behavioral, cognitive and/or emotional responses to stimuli aimed at
characterizing the behavioral responses that will form the basis of an
intervention; (2) formative research to determine attitudes and preferences
with regard to specific intervention approaches and intervention components;
(3) “proof
of concept” and small-scale safety/efficacy studies (early phase trials) that
translate the concepts and findings from previous basic science research into
specific, novel interventions, demonstrate safety, and characterize the
interventions and their effects in controlled settings; and (4) pilot/feasibility studies to test and refine intervention procedures to be used in the specific
populations of interest and to determine the acceptability and feasibility of
interventions in clinical and community settings.

Applicants
may propose the use of innovative study designs for building and optimizing
behavioral and systems interventions, for example (1) adaptive treatment
designs that customize an intervention strategy to the individual,
evaluate for whom a treatment should be employed, or when it should change over
time in order to maximize its effects; or (2) systems science approaches
that determine how, when and with whom to intervene in a social group, family,
health care setting, neighborhood, community, or other system.

Selected
Research Examples

The following
are intended only as conceptual examples of the types of topics and approaches
relevant to the proposed FOA, and should not be regarded as a call to pursue
any specific line of investigation:

Research on learning, cognition, information processing,
persuasive communications and message framing can allow a better understanding
of how individuals interpret information provided through dietary and physical
activity messages, and how they use diaries and other methods of tracking and
calculating daily dietary and physical activity patterns (e.g., balancing
calories and fat intake throughout the day, using food and activity records to
monitor dietary intake and physical activities over time). Applications of
findings from these areas could result in more potent interventions for
teaching children and adults about healthy eating and activity levels, as well
as encouraging adherence to self-monitoring, goal-setting, and other behavioral
strategies that are important components of many weight control programs.

Based on research findings about neural influences on
obesity and the role of stress in eating behavior, studies might evaluate
methods for interrupting the signaling pathway that leads to abdominal fat
deposition in response to stress, and/or test the effects of incorporating
stress-reduction methods into obesity prevention and treatment programs.

Modeling techniques (e.g., network analyses and systems
dynamics approaches) aimed at examining the behavior of complex social and
behavioral systems could be used to better understand how an individual’s
social relationships influence engagement in physical activities and dietary
behaviors, and to determine how and with whom to intervene in a person’s social
network to best encourage healthy lifestyle behaviors.

Research translating laboratory or observational obesity
studies into new avenues for intervention or prevention could result in more
effective weight management approaches. Applications might include translation
of findings in areas such as sensory response and food intake; interoceptive
awareness, emotional overeating and eating in the absence of hunger; the influence
of sleep or sleep deprivation on appetite, physical activity and sedentariness;
emotional and behavioral self-regulation and eating behavior; and eating or
activity in response to environmental, social or emotional cues.

New paradigms of science (e.g., chaos theory,
non-linear models) that address the unpredictability of behavior can inform
interventions to identify conditions that foster motivation for behavior change
and strategies that maximize chances for non-linear, non-rational change, such
as occurs in certain natural phenomena (e.g., “tipping points” in disease and social
epidemics).

Approaches derived from engineering models aimed at
transforming environmental systems over time to promote desirable behavior or
outcomes(e.g., cruise control, insulin pumps, the programmable thermostat) could be
used to structure systems such as neighborhoods, worksites, schools and homes
to promote healthy, as opposed to unhealthy, behaviors.

Recent research concerning genetic predispositions to
obesity-related behaviors could be used to develop novel intervention
approaches or to enhance existing approaches to increasing physical activity,
reducing sedentariness and improving dietary behaviors.

New interdisciplinary areas of science such as
behavioral economics and neuroeconomics are developing and testing theories
about the most potent forms, frequency and duration of rewards and reinforcements for encouraging and discouraging behavior. Applications
include the development of more precise and targeted reward and reinforcement schedules for use in dietary, sedentariness, and physical
activity intervention programs, and the testing of economic incentives, tax
structures, food labeling and other policies to encourage industry, local
governments, and community organizations to alter environments and market
products that promote healthy food choices and physical activity.

Neuroscience researchers, using data from imaging techniques
that map the brain regions and neural processes underlying addictive and
appetitive behaviors, could collaborate with cognitive and social psychologists
studying impulsivity, emotional dysregulation and risk-taking behavior, to
better design interventions that prevent cravings, promote delayed
gratification, and improve individuals’ abilities to cope with
relapse-eliciting stimuli, such as food ads or presence of unhealthy foods in
the social environment.

The
emphasis in these CBIDs is on development of behaviorally-based interventions to reduce obesity and improve obesity-related behaviors; however,
interventions that incorporate the use of biological agents (drugs, devices)
are allowed, as long as the biological features of the intervention being
developed occur in the context of or in combination with a behavioral strategy,
and not as stand-alone interventions.

Plan for Intervention Development

Projects
submitted must include an overall plan for intervention development, which will
include a timeline or flowchart showing types, sequence, and duration of each study
and the milestones to be achieved for each study within the Intervention
Development plan. The plan will describe the particular problem or focus of study concerning
obesity prevention or treatment for which their intervention will be developed;
provide a detailed description of the basic biological, behavioral and/or
social science research findings being used to inform intervention development
and (where relevant), the theoretical model that will be applied to development
of the intervention; describe key features of the intervention to be developed,
phases of the intervention development process and specific studies to be
conducted in developing the intervention; outline the goals and objectives of
the intervention, describe the population and behaviors that are targets of the
intervention, the hypotheses to be tested, the specific outcomes to be assessed
and the criteria or milestones to be achieved in determining progress and/or
intervention success at each stage of the intervention development process.

Stages of
Intervention Development. The following presents the stages of research
and the types of studies within each stage that should be included as part
of the applicant’s intervention development proposal; for each stage, the approximate expected duration of the stage is given:

(1)
Defining the Intervention (6 months – 1 year)

During this
stage, applicants may conduct foundational studies to refine understanding of
the basic biological, behavioral or social science research finding(s) or
concepts being used in relation to the particular intervention (e.g., dietary
or physical activity behaviors) and/or population of interest. These
experimental, observational and/or formative studies must be related to the
development of the proposed intervention(s), (e.g., to elucidate the behaviors
being targeted for intervention, the characteristics of individuals for whom
the intervention is being developed, and/or the psychophysiologic processes
involved in the intervention process being studied).

The types
of studies to be proposed for this stage include:

Laboratory
or field experiments or observational studies necessary to develop the
intervention of interest, including studies of behavioral, cognitive
and/or emotional responses to stimuli to deconstruct and quantify the
behavioral responses that will form the basis of an intervention,
psychophysiologic research to delineate biological and behavioral
processes underlying the relationship of psychosocial risk factors and
obesity-related behaviors, and/or studies to delineate how an
intervention can best be targeted to subgroups of respondents based on
particular psychological, behavioral, or physiological characteristics of
these respondents; and/or

Formative
research, involving ethnographic interviews, focus groups, cognitive
testing, and other accepted qualitative research methods designed to
engage the community of participants in the development of strategies
(user-centered design), explore the acceptability of the approach being
used, and assess attitudes, norms, values, and meanings of relevance to
the population being targeted in order to guide development of the
intervention.

In addition
to the above types of studies, secondary analyses of existing data (qualitative
or quantitative) may be used as an additional (but not the sole) source of
information to aid in defining the intervention and to guide later stages of
the intervention development process.

(2)
Characterizing the Intervention’s Effects (2 – 3 years)

This stage
consists of safety, “proof of concept” and small-scale efficacy studies that
translate the concepts and findings from previous basic science research into
specific, novel interventions in the areas of dietary behavior and physical
activity. In this stage, applicants should propose any one or more of the
following types of studies which are aimed at developing, refining and
characterizing the intervention:

1. Phase I studies to determine the
safety of the intervention or intervention components, and Phase
II research that investigates: effects of the intervention on the
outcomes of interest; effects of individual components of an intervention
versus combinations; effects of varying an intervention’s content, timing, mode
of delivery, duration and frequency of contact; and dose-response relationships
(effects of varying the intensity of an intervention or its components on
outcomes of interest).

2. Studies using adaptive designs and pre-specified decision
rules based on participant characteristics and responses to treatment to
customize the intervention strategy to the individual, evaluate for whom a
treatment should be employed, or when it should change over time in order to
maximize its effects.

3. Studies using modeling
techniques and systems science approaches (e.g., network analyses and systems
dynamics approaches) to develop interventions and suggest how, when and where
they should be targeted within a social group, family, health care or other
system to achieve maximum benefit.

(3)
Assessing Feasibility and Refining the Intervention (1 - 2 years)

In this
stage, applicants will conduct pilot/feasibility studies to ensure the
intervention procedures can be performed in the specific populations and
settings of interest, to refine the intervention, and to gather data in
preparation for future RCTs of the intervention. These studies may use
combinations of qualitative (focus groups, ethnographic interviews) and
quantitative (small-scale pilot studies) methods to determine the acceptability
and feasibility of the intervention within the populations and setting(s) of
interest, and to evaluate the effects of tailoring interventions to
subpopulations of interest.

These
studies may also be used to refine intervention and measurement procedures, gain experience in and
information concerning screening, recruitment and retention of the target
population (e.g., estimates of yield, pre-testing of screening/recruitment
procedures), determine estimates of variability and levels of response in the
target population, obtain preliminary information about sustainability and
cost-effectiveness of the intervention, and engage community residents and
leadership in preparation for future large-scale randomized trials of the intervention.

Timeline,
Goals and Milestones. The intervention
development plan should be based on a clearly stated project timeline that
includes practical, achievable goals, and project milestones. Milestones toward
intervention development are goals that create go/no-go decision points in the
project, including quantitative success criteria. Applications should include a linear
timeline or flowchart of project tasks and milestones, including the stages and types, sequence and expected duration of
studies to be performed, and the milestones/criteria needed to proceed to the
next stage.

It
is understood that during the intervention development process, some deviation
from this timeline may occur based on study results; for example, findings at
one stage may require a return to an earlier stage to further refine an
intervention or its conceptual basis. In addition, although studies are
expected to be conducted in sequential fashion, some projects may be performed
concurrently, as when multiple components of an intervention are being
developed simultaneously, or tools and materials relevant to several aspects of
an intervention are being evaluated in separate, concurrent studies.
Applicants should propose their best estimate of the sequence of studies,
timeline and milestones needed to develop the proposed intervention.

Applicants
should also provide preliminary evidence of their ability to recruit
participants, to provide appropriate oversight of participants, and to maintain
high rates of participant follow-up throughout the intervention development
process. Studies should incorporate quality control procedures for
measurements, data collection, and data management, as well as for assuring
fidelity to intervention delivery.

Protocol
and manual of procedures development. At the beginning of the intervention development process,
Investigators will be expected to develop, and then to refine during subsequent
stages, an intervention protocol and an intervention procedures manual. These
documents will include a detailed description of the rationale, theoretical
basis and basic science findings guiding development of the intervention; a set
of proposed procedures to be developed, evaluated and finalized during
subsequent stages; description of the development or adaptation of relevant
measures including diagnostic, screening and outcome assessment tools; and
description of quality control procedures and measures to be used to ensure and
assess intervention fidelity, including intervention delivery and adherence to
the protocol. Components of the intervention to be developed should be in
operation in the manual of procedures in as much detail as appropriate
commensurate with its present state of development. These documents (protocol and
manual of procedures) are to be finalized at the end of the intervention
development period.

Facilities
and Environment

All
applicants must provide evidence that the institution or institutions in which
the research will take place have the infrastructure, resources and
institutional support needed to facilitate interdisciplinary, collaborative
research across basic and applied research boundaries. Applicants must
demonstrate the availability of adequate laboratory, clinical, office and other
facilities needed to carry out the objectives of the proposed Centers for
Behavioral Intervention Development program. To the extent possible it is
desirable for CBIDs to have a commitment for sufficient contiguous space so
that the Center has a high degree of cohesion and visibility. Internet access
to scientific literature and other information must be readily available.
Relevant support services, including for example adequate data processing
facilities, must also be readily accessible and documented in the proposal.

Successful applicants will provide
evidence that the research teams assembled as part of the CBID span at
least three separate disciplines in areas relevant to the topic of
investigation, including the social and behavioral sciences (e.g., psychology,
sociology, anthropology), medical fields of study (e.g., neurosciences, metabolic biology, behavioral genomics, cardiovascular
medicine, pharmacology, nutrition science), and related fields such as
economics, business (marketing), health policy, environmental
redesign, urban planning, engineering, informatics, communication
sciences, humanities, exercise sciences, and other disciplines.

Applicants
must show they have access to communities (e.g., individuals, families,
schools, neighborhoods) and/or clinical care settings (primary care and
specialty clinics) in which the interventions will ultimately be used.
Applicants should outline the community and clinical engagement
activities to be conducted to ensure that the proposed obesity-related intervention(s)
can be developed with community involvement and evaluated for acceptability and
feasibility within non-academic (i.e., community and clinical practice)
settings.

Applicants
from institutions housing transdisciplinary, translational programs (such as
Clinical and Translational Science Awards [CTSAs], NIH Roadmap Interdisciplinary
Research Center Awards, Individual IC Transdisciplinary Centers and similar
programs) are encouraged to apply, although applicants need not be from these programs
and institutions to be successful.

Areas
of research that will not be considered responsive to the FOA include:

Formative or qualitative research only.

Primary
focus of prospective or descriptive epidemiology (e.g., investigations of
the health risks of obesity).

Primary
focus on causation of obesity, mechanisms of energy balance, or basic
research on obesity or obesity-related behaviors only.

Phase
III clinical or community trials.

Translation
II research (effectiveness trials or research on the dissemination of
proven intervention strategies).

Applications
that do not include studies in humans.

Primary focus on research resource
development.

Projects that do not include a phased approach to
intervention development using a combination of the types of studies
outlined above and a timeline with specific milestones for achieving study
goals.

Program Organization and Coordination

The
studies supported by this FOA will not use a common study protocol.
However, after awards are made, investigators may wish to collaborate on
developing and reporting standardized measures of key common variables, such as
height, weight, dietary intake, physical activity, smoking status, and
population characteristics. Investigators may also collaborate in the
development of formative assessment measures, such as interview or survey
instruments and focus group guidelines. The use of common study variables,
criteria, and protocols to facilitate meta-analysis of the studies when
possible is highly encouraged.

Investigators should
indicate in their application their willingness to collaborate on the
development and use of standardized measurement protocols, where applicable,
identification of eligibility criteria, formative assessment methods, data
analysis, and their willingness to collaborate with NHLBI and NIH scientists in
all aspects of the study. The cooperative agreement mechanism will be
used and a Steering Committee formed to facilitate collaboration (see Section
VI.2.A, Cooperative Agreement Terms and Condition of Award.)

Each
awardee is responsible for refining and finalizing his/her protocols and for
conducting the research. Awardees should oversee implementation of the
development of their interventions and adherence to their protocols, and assure
appropriate quality control procedures are in place. Each awardee will be
responsible for training and certification of his/her personnel.

The
NHLBI will be substantially involved with the awardees in a partnership.
The NHLBI Program Scientist will monitor patient recruitment and study
progress, ensure disclosure of conflicts of interest, and assure adherence to
NHLBI policies. NHLBI will appoint a Data and Safety Monitoring Board
(DSMB) and appoint a chairperson of the Steering Committee among Principal
Investigators.

A
Steering Committee will be an important body for this project. The
Steering Committee is composed of the Principal Investigators of the CBID and
the NHLBI Program Scientist, each of whom will have one vote. The
Steering Committee will meet in-person three times a year through the project.
The Committee will meet by teleconference on at least a monthly basis.

A
DSMB will be established to monitor data and oversee participant safety in all
of the studies supported by this initiative. At the first meeting, the
DSMB will review the awardees protocols. Subsequently, the DSMB will
monitor and review recruitment, adverse events, data quality, outcome data, and
overall awardee performance. It has the responsibility to review interim
data and final data, and recommend whether protocols should be modified, and
whether studies should be continued or should be terminated early. Thus,
its ethical responsibilities to the participants, as well as to the integrity
of the study, are of paramount importance to the NHLBI. The DSMB will
meet at least twice each a year, and more frequently if needed. At least one of the
meetings each year will be in person.

A
DSMB will be responsible for monitoring the funded projects and will report to
the Director of the NHLBI. Therefore, applicants should not appoint DSMB
members in advance of the peer review, or even inquire about the interest of
possible DSMB members, because anyone so contacted would not be eligible to
serve as a member of the peer review committee that will evaluate the
applications for scientific merit.

In
addition to the DSMB meetings, each awardee will be required to attend Steering
Committee meetings in which study plans, findings, and issues of common
interests and concerns will be shared and discussed. Each applicant mustinclude in his/her
budgets funds for attending these meetings. For budgeting purposes, the
applicants should assume that in addition to DSMB meetings, in-person meetings
will be convened three times during the first funding year and twice a year for
each funding year thereafter. Applicants should assume for budgeting
purposes that the meetings will be for two days in the Washington, DC, metro area and will require the attendance of the Principal Investigator and one other
person.

Research and Coordination Unit

Tofacilitate
coordination of research activities between awardees, this FOA will also
support the costs of a Resource and Coordination Unit (RCU) by one of the
awardees for this FOA. In consultation with the awardees and NIH, the RCU
will be responsible for conducting a number of tasks, including the following:

Assess the potential for
and facilitate the selection of any common measures and methods (e.g., compile
a list of proposed common measures, review relevant literature, and assess the
advantages and disadvantages for common measures).

Develop a
website and email system for group communication.

Arrange all
conference calls (at least once per month).

Coordinate
the semi-annual meetings and reports to the DSMB.

Plan the
agenda and handle the logistics of in-person meetings in the Washington, DC, metro area.

Post
minutes of the conference calls and in-person meetings on a program
website.

Support
committees that investigators would want to form for collaboration.

Facilitate
information exchange across the FOA studies and NHLBI.

Develop and
implement common formats for reports, protocols and descriptions.

Lead
efforts to conduct cross-study analyses (e.g., meta-analyses).

Coordinate preparation of scientific
publications and dissemination of findings from the studies, if appropriate.

Develop and implement an evaluation
protocol for the initiative.

Applicants
are strongly encouraged to apply for both the research and RCU components of
this FOA. Applicants wishing to do so should propose to perform the resource
and coordination functions in addition to conducting their own study. Applicants proposing to
perform the resource and coordinating unit function should describe how these
activities will be performed in a separate section of the application that
addresses the critical elements for these functions specified in this
FOA. Up to five additional pages will be allowed to describe these
functions. Applicants should submit a separate
budget for the RCU, including the cost of meeting rooms and equipment for
in-person meetings. The
budget and budget narrative should include the direct and facility and
administrative (F&A) costs for the RCU component not to exceed the funding
levels provided in Section II.2.

Please Note: The evaluation of the
RCU will be separate from the overall review of the scientific merit of the
application (see Section IV. 2.B).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative
agreement mechanism, the Project Director/Principal Investigator (PD/PI)
retains the primary responsibility and dominant role for planning, directing,
and executing the proposed project, with NIH staff being substantially involved
as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements,
"Cooperative Agreement Terms and Conditions of Award."

At this
time, it is not known if this FOA will be reissued.

2. Funds
Available

The NHLBI intends to commit up to $5 million in total costs
in FY09 to fund four to six applications in response to this FOA; NCI intends
to commit up to $1 million in total costs in FY09 to fund one application;
NIDDK intends to commit up to $750,000 in total costs in FY09 or FY10 to fund
one application; and OBSSR intends to commit up to $200,000 in total costs in
FY09 to co-fund one application. Each applicant may request a project period
of five years and a budget for direct costs of up to $3,750,000 over the
five-year period, with a limit of $750,000 in direct cost for any single
year. One of the awards will serve additionally as a Resource and
Coordination Unit (RCU) to facilitate cross-study activities. It is
anticipated that the maximum award for the RCU will be approximately $1,000,000
in direct costs over five years. The RCU costs are in addition to the
intervention development costs. Applicants are strongly encouraged to
apply for both the research and RCU components of this FOA. A total of up to
$25 million in total costs is available from NHLBI over the five-year period
for the program, up to $5 million in total costs is available from NCI, up to
$3,750,000 in total costs is available from NIDDK , and up to $1 million in
total costs is available from OBSSR.

Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.

Facilities and Administrative (F&A) costs requested by consortium
participants are not included in the direct cost limitation. See NOT-OD-05-004.

The
decision of whether to apply for a grant with a single PD/PI or multiple
PDs/PIs is the responsibility of the investigators and applicant organizations,
and should be determined by the scientific goals of the project. Applications
for grants with multiple PDs/PIs will require additional information, as
outlined in the instructions below. The NIH review criteria for approach,
investigators, and environment have been modified to accommodate applications
involving either a single PD/PI or multiple PDs/PIs. When considering multiple
PDs/PIs, please be aware that the structure and governance of the PD/PI
leadership team as well as the knowledge, skills and experience of the
individual PDs/PIs will be factored into the assessment of the overall
scientific merit of the application. Multiple PDs/PIs on a project share
the authority and responsibility for leading and directing the project,
intellectually and logistically. Each PD/PI is responsible and accountable
to the grantee organization, or, as appropriate, to a collaborating organization,
for the proper conduct of the project or program, including the submission of
required reports. For further information on multiple PDs/PIs, please see https://grants.nih.gov/grants/multi_pi.

Due to the unique requirements of this FOA, applicants are strongly encouraged
to consult with NHLBI Program Staff as plans for an application are being
developed. This early contact will provide an opportunity to clarify the
applicant's understanding of program goals and guidelines, including the scope
of projects within the program and program requirements.

Any
collaborators, consultants, or subcontractors should be identified no matter
when during the conduct of the activity the proposed interaction occurs. Since
translational research is intrinsically interdisciplinary, this plan will often
involve cooperation among basic and applied researchers as well as clinicians,
and may include the participation of private-sector companies and voluntary
organizations.

Applicants
are not permitted to submit a resubmission application in response to this FOA.

Applications must
be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a D&B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be
entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page of the application form, and the YES
box must be checked.

Every
effort should be made to comply with the format specifications, which are based
upon a standard U.S. paper size of 8.5” x 11” within each PDF.

Funds for
up to 8 percent Facilities and Administrative (F&A) costs (excluding equipment) may be
requested. See NOT-OD-01-028, March 29, 2001.

Organizations
must comply with Federal/NIH policies on human subjects, animals, and
biohazards.

Organizations
must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., “Administrative and National Policy
Requirements.”

Proposed
research should provide special opportunities for furthering research programs
through the use of unusual talent, resources, populations, or environmental
conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Applications with Multiple PDs/PIs

When
multiple PD/PIs are proposed, use the Face Page-Continued page to provide items
3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact
PD/PI” for all communications between the PD/PIs and the agency. The contact
PD/PI must meet all eligibility requirements for PD/PI status in the same way
as other PD/PIs, but has no special roles or responsibilities within the
project team beyond those mentioned above. The contact PD/PI may be changed
during the project period. The contact PD/PI should be listed in block 3 of
Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page
1-Continued. When inserting the name of the PD/PI in the header of each
application page, use the name of the “Contact PD/PI, et. al.” The contact
PD/PI must be from the applicant organization if PD/PIs are from more than one
institution.

All
individuals designated as PD/PI must be registered in the eRA Commons and must
be assigned the PD/PI role in that system (other roles such as SO or IAR will
not give the PD/PI the appropriate access to the application records). Each
PD/PI must include their respective eRA Commons ID in the eRA Commons User Name
field.

All
projects proposing Multiple PDs/PIs will be required to include a new section
describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple
PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI
Leadership Plan” must be included. A rationale for choosing a multiple PD/PI
approach should be described. The governance and organizational structure of
the leadership team and the research project should be described, and should
include communication plans, process for making decisions on scientific
direction, and procedures for resolving conflicts. The roles and
administrative, technical, and scientific responsibilities for the project or
program should be delineated for the PDs/PIs and other collaborators.

If
budget allocation is planned, the distribution of resources to specific
components of the project or the individual PDs/PIs should be delineated in the
Leadership Plan. In the event of an award, the requested allocations may be
reflected in a footnote on the Notice of Award.

Prospective
applicants are asked to submit a letter of intent that includes the following
information:

Descriptive
title of proposed research

Name,
address, and telephone number of the Principal Investigator

Names of
other key personnel

Participating
institutions

Number and
title of this funding opportunity

Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.

Applications must
be prepared using the forms found in the PHS 398 instructions for preparing a
research grant application. Submit a signed, typewritten original of the
application, including the checklist, and three signed photocopies in one
package to:

Applications must
be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that
date, the application may be delayed in the review process or not
reviewed. Upon receipt, applications will be evaluated for completeness
by the CSR and for responsiveness by the reviewing Institute Incomplete and/or
non-responsive applications will not be reviewed.

The
NIH will not accept any application in response to this funding opportunity
that is essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity must not include an Introduction describing the changes and
improvements made, and the text must not be marked to indicate the changes from
the previous unfunded version of the application.

All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at NIHGrants Policy Statement.

Pre-award
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or renewal
award if such costs: (1) are necessary to conduct the project, and (2) would be
allowable under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or
non-competing award imposes no obligation on NIH either to make the award or to
increase the amount of the approved budget if an award is made for less than
the amount anticipated and is inadequate to cover the pre-award costs incurred.
NIH expects the grantee to be fully aware that pre-award costs result in
borrowing against future support and that such borrowing must not impair the
grantee's ability to accomplish the project objectives in the approved time
frame or in any way adversely affect the conduct of the project (see theNIH Grants Policy Statement).

6. Other Submission
Requirements and Information

Applications must include the following:

Budget for staff to conduct data
entry at their CBIDs, and for any equipment needed for data collection and
intervention delivery.

Estimates of travel costs for
in-person investigator meetings (three the first funding year, two thereafter)
and semi-annual DSMB meetings (at least one must be in person in the Washington, DC, metro area) to
review the study progress, as detailed under the section on Special
Requirements, along with statements indicating willingness to participate in
these meetings.

For applicants proposing to become
the resource and coordinating unit (RCU) for this FOA, a description of how
resource and coordinating functions will be performed, which addresses the
critical elements for these functions specified in this FOA, should be included
in the application. Up to five additional pages will be allowed to
describe these functions. The budget for resource and coordinating units
(RCU) should be provided separately.

Awardees
must agree to the "Cooperative Agreement Terms and Conditions of
Award" in Section VI.2.A "Award Administration Information."

Do
not use the Appendix to circumvent the page limitations of the Research Plan
component. An application that does not comply with the required page
limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH
considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value and further the
advancement of the research. When resources have been developed with NIH funds
and the associated research findings published or provided to NIH, it is
important that they be made readily available for research purposes to
qualified individuals within the scientific community. If the final
data/resources are not amenable to sharing, this must be explained in the
Resource Sharing section of the application (see https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(b) Sharing Model Organisms: Regardless of the amount requested, all
applications where the development of model organisms is anticipated are
expectedto include a description of a specific plan for sharing
and distributing unique model organisms and related resources or state
appropriate reasons why such sharing is restricted or not possible (see Sharing
Model Organisms Policy, and NOT-OD-04-042).

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount
requested, applicants seeking funding for a genome-wide association
study are expected to provide a plan for submission of GWAS data to the
NIH-designatedGWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. A
genome-wide association study is defined as any study of genetic variation
across the entire genome that is designed to identify genetic associations with
observable traits (e.g., blood pressure or weight) or the presence or absence
of a disease or condition. For further information see Policy for Sharing
of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies
(go to NOT-OD-07-088, and https://grants.nih.gov/grants.

Specific Instructions for Foreign Applications

All
foreign applicants must complete and submit budget requests using the Research
& Related Budget component found in the application package for this FOA. SeeNOT-OD-06-096, August 23, 2006.

Section V. Application Review Information

1.
Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the
review criteria described below will be considered in the review process.

2. Review and Selection
Process

Applications that are complete and responsive to this FOA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NHLBI and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review
criteria stated below.

As part of
the scientific peer review, all applications will:

Undergo a selection process in which
only those applications deemed to have the highest scientific and technical
merit, generally the top half of applications under review, will be discussed
and assigned a priority score.

Receive a written critique.

Receive a second level of review by
the appropriate national advisory council or board.

Applications
submitted in response to this FOA will compete for available funds with all
other recommended applications submitted in response to this FOA. The following
will be considered in making funding decisions:

Scientific merit of the proposed
project as determined by peer review

Availability of funds

Relevance of the proposed project to
program priorities

The goals
of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, and weighted as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a meritorious priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.

Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge or clinical
practice advance? What will be the effect of these studies on the concepts,
methods, technologies, treatments, services, or preventive interventions that
drive this field?

Approach: Are the conceptual or clinical
framework, design, methods, and analyses adequately developed, well integrated,
well reasoned, and appropriate to the aims of the project? Does the applicant
acknowledge potential problem areas and consider alternative tactics? For
applications designating multiple PDs/PIs, is the leadership approach,
including the designated roles and responsibilities, governance, and
organizational structure, consistent with and justified by the aims of the
project and the expertise of each of the PDs/PIs? Does the applicant provide a
detailed description of the basic biological, behavioral and/or social science
research findings being used to inform intervention development and the
theoretical model that will be applied? Does the applicant propose a
phased approach to translating basic behavioral, biological and/or social
science findings into interventions? Is the phased approach aimed at
determining the safety profile of the treatment and characterizing the effects
of the intervention including the “dosages” required (i.e., intensity,
frequency, and duration of intervention) to effect change in the intermediate
outcomes in specific patient groups under well-specified conditions? Does the
applicant include studies from all three phases described in the FOA (defining
the intervention, characterizing the intervention’s effects, and refining and
assessing feasibility of the intervention) to include a combination of the
following: experimental or observational studies and/or formative research;
“proof of concept” and small-scale safety/efficacy studies (early phase trials)
or, alternatively, adaptive treatment designs or systems science approaches;
and pilot/feasibility studies? Does the applicant adequately describe key
features of the intervention to be developed, phases of the intervention
development process and specific studies to be conducted in developing the
intervention? Are the goals and objectives of the intervention, the hypotheses
to be tested, the population and behavioral targets of the intervention, and
the outcomes to be assessed for each study proposed clearly described?
Does the applicant include a clearly stated project timeline or flow
chart that includes a logical progression of studies through the stages of
intervention development described in this FOA, the applicant’s best estimate
of the sequence and duration of studies, as well as practical, achievable
goals, and clear, objective criteria or milestones to be achieved in
determining progress and/or intervention success at each stage of the
intervention development process? Are sample sizes justified and adequate
to achieve the goals of each study? Does the applicant provide evidence
of his or her ability to recruit participants, to provide appropriate oversight
of participants, and to maintain high rates of participant follow-up throughout
the intervention development process? Are quality control procedures for
measurements, data collection, data management, as well as for assuring
fidelity to intervention delivery, adequately described? Are the informed
consent procedures, selection or randomization procedures, and statistical analyses
appropriate for the study designs selected?

Innovation: Is the project original
and innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area? Does the
project seek to develop, characterize and refine new, innovative
obesity-reducing strategies rather than evaluating the effectiveness of already
well-defined or proven strategies?

Investigators: Are the PD(s)/PI(s) and other
key personnel appropriately trained and well suited to carry out this work? Is
the work proposed appropriate to the experience level of the principal investigator
and other researchers? Do(es) the PD(s)/PI(s) and investigative team bring
complementary and integrated expertise to the project (if applicable)?
Does the research team span at least three separate disciplines in areas
relevant to the topic of investigation, including the social and behavioral
sciences (psychology, sociology, anthropology), medical fields of study
(neurosciences, metabolic biology, behavioral genomics, cardiovascular
medicine, pharmacology, nutrition science), and related fields such as
economics, business (marketing), health policy, environmental redesign, urban
planning, engineering, informatics, communication sciences, humanities,
exercise sciences, and other disciplines? Does the research team have
sufficient formative, experimental and clinical trial experience? Does at least
one member of the research team have appropriate experience with targeting
interventions to minorities and women, as appropriate, and/or to the specific
age groups or other populations targeted? Do(es) the Principal Investigator(s)
have prior experience with collaborative research?

Environment: Do(es) the scientific
environment(s) in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Does the applicant provide evidence that the institution or
institutions in which the research will take place have the infrastructure,
resources and institutional support needed to facilitate interdisciplinary,
collaborative research across basic and applied research boundaries and across
diverse scientific disciplines? Are adequate laboratory, clinical, office
and other facilities needed to carry out the objectives of the proposed program
available? If interventions are environmental or involve an
environmental component, are collaborations and ties with the
community/institutions to host the intervention sufficiently demonstrated, e.g.,
in letters of support? Does the applicant show access to communities
(individuals, families, schools, neighborhoods) and/or clinical care settings
(primary care and specialty clinics) in which the interventions will ultimately
be used? Are the community and clinical engagement activities to be
conducted to ensure that the obesity-related intervention(s) developed can be
evaluated for acceptability and feasibility within non-academic (i.e.,
community and clinical practice) settings adequately outlined?

In addition
to the above review criteria, the following criteria will be addressed and
considered in the determination of scientific merit and the rating.

Collaboration: Have the investigators stated their
willingness to collaborate with NHLBI and NIH scientists and staff and with
Investigators and staff from other grants supported by this initiative?
Is there evidence that the applicant is willing to collaborate on the
development and use of key common measures and measurement protocols, such as
height, weight, adherence to dietary and physical activity behaviors? Is there
evidence the applicant is willing to collaborate, where applicable, on
identification of eligibility criteria, formative assessment methods,
identification of criteria/milestones to guide progression through the stages
of intervention development, and data analysis, and to provide information and
data for Steering Committee and DSMB reports?

2.A. Additional Review Criteria:

In addition to the
above criteria, the following items will be considered in the determination of
scientific merit and the rating:

Protection
of Human Subjects from Research Risk: The involvement of human subjects and
protections from research risk relating to their participation in the proposed
research will be assessed (see the Research Plan section on Human Subjects in
the PHS 398 instructions).

Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan section on Human Subjects in the
PHS 398 instructions).

Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the
project, the five points described in the Vertebrate Animals section of the
Research Plan will be assessed.

Biohazards: If materials or
procedures are proposed that are potentially hazardous to research personnel
and/or the environment, determine if the proposed protection is adequate.

2.B.
Additional Review Considerations

Resource and Coordination Unit (RCU): The
adequacy of the plan for the Resource and Coordination Unit (RCU) will be
assessed by the reviewers. However, reviewers will not factor the
proposed RCU plan into the determination of scientific merit or the priority
score. Each plan will receive a secondary priority score specific to the
RCU which is separate from the primary priority score of the parent
application. The following criteria will be used:

Significance: Does the applicant address the importance of
performing resource and coordinating functions in order to enhance the value of
the research program?

Approach: Are the proposed approaches appropriate for
facilitating coordination and serve as a resource among awardees? Are
state-of-the-art coordinating and resource strategies proposed?

Environment: Is there evidence of institutional support?
Does the applicant have prior experience in performing coordinating functions?

Budget and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation to the
proposed research may be assessed by the reviewers. The priority score should
not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether the project
presents special opportunities for furthering research programs through the use
of unusual talent, resources, populations, or environmental conditions in other
countries that are not readily available in the United States or that augment
existing U.S. resources will be assessed.

2.C. Resource Sharing Plan(s)

When
relevant, reviewers will be instructed to comment on the reasonableness of the
following Resource Sharing Plans, or the rationale for not sharing the
following types of resources. However, reviewers will not factor the proposed
resource sharing plan(s) into the determination of scientific merit or priority
score, unless noted otherwise in the FOA. Program staff within the IC will be
responsible for monitoring the resource sharing.

A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.

Selection of an application for award is not an authorization to begin
performance. Any costs incurred before receipt of the NoA are at the
recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

The
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.

2.A.
Cooperative Agreement Terms and Conditions of Award

The
following special terms of award are in addition to, and not in lieu of,
otherwise applicable U.S. Office of Management and Budget (OMB) administrative
guidelines, U.S. Department of Health and Human Services (DHHS) grant
administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable
when state
and local governments
are eligible to apply), and other HHS, PHS, and NIH grant administration
policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic involvement
with the awardees is anticipated during the performance of the activities.
Under the cooperative agreement, the NIH purpose is to support and stimulate
the recipients' activities by involvement in and otherwise working jointly with
the award recipients in a partnership role; it is not to assume direction,
prime responsibility, or a dominant role in the activities. Consistent with
this concept, the dominant role and prime responsibility resides with the
awardees for the project as a whole, although specific tasks and activities may
be shared among the awardees and the NIH as defined below.

2.
A.1. Principal Investigator Rights and Responsibilities

The
PD(s)/PI(s) will have the primary responsibility for: The awardee(s) will
have lead responsibilities in all aspects of the study, including any
modification of study design, conduct of the study, quality control, data
analysis and interpretation, preparation of publications, and collaboration
with other investigators, unless otherwise provided for in these terms or by
recommendation of the Steering Committee.

Study
investigators are encouraged to publish and to release publicly and disseminate
results and other products of the study, in accordance with study protocols and
governance. Within three years of the end of the period of NIH support
for the project, data not previously released and other study materials or
products not previously distributed are to be made available to individuals who
are not study investigators, provided such release is consistent with the study
protocol and governance and with 2.A.2, paragraph 3 below. In addition,
study investigators must establish a plan for making data sets and materials
available to the scientific community and to the NIH immediately upon completion
of the three year period following the end of the period of NIH support.

Awardees will retain custody of and have primary rights to the data and
software developed under these awards, subject to Government rights of access
consistent with current DHHS, PHS, and NIH policies.

2.
A.2. NIH Responsibilities

An NIH
Project Scientist will have substantial programmatic involvement that is above
and beyond the normal stewardship role in awards, as described below.

The NIH Project Scientist will serve on the Steering committee; he/she or other
NIH scientists may serve on other study committees, when appropriate. The NIH
Project Scientist (and other NIH scientists) may work with awardees on issues
coming before the Steering Committee and, as appropriate, other committees,
e.g., recruitment, intervention, follow-up, quality control, adherence to
protocol, assessment of problems affecting the study and possible changes in
protocol, interim data and safety monitoring, final data analysis and
interpretation, preparation of publications, and development of solutions to
major problems such as insufficient participant enrollment.

Final decision-making authority on matters of
budgetary and funding actions, grants management actions, and management of
intellectual property issues is assigned to NHLBI staff other than the Project
Scientist. The responsibility for final decision making may reside with Senior
Institute management, separate organizational components and/or oversight
committees. Because it is anticipated that the Project Scientist will
participate in activities that rise to a level of involvement that results in
conflicts of interest, for example, co-publication, etc., other staff members
such as direct line supervisors and/or other Senior NHLBI Program management
staff will serve as agency Program Officials and will be responsible for the
normal scientific and programmatic stewardship of the award. The
NHLBI policy on authorship and manuscript review of NHLBI sponsored extramural
research protects against conflicts of interest with the Program Officer.

The
NIH reserves the right to withhold fundingor curtail the study (or an individual award) in
the event of (a) failure to develop or implement a mutually agreeable
collaborative protocol; (b) substantial shortfall in participant recruitment, follow-up, data
reporting, or quality control; (c) major breach of the protocol or substantive changes
in the agreed-upon protocol with which NIH cannot concur; (d) attainment of a major study
endpoint before schedule with persuasive statistical significance; or (e) human
subject ethical issues that may dictate a premature end of the award.

Support
or other involvement of industry or any other third party in the study -- e.g.,
participation by the third party; involvement of study resources or citing the
name of the study or NIH support; or special access to study results, data,
findings or resources -- may be advantageous and appropriate. However, except
for licensing of patents or copyrights, support or involvement of any third
party will occur only following notification of and concurrence by NIH.

Additionally, an agency program official or NIH program director will be
responsible for the normal scientific and programmatic stewardship of the award
and will be named in the award notice.

The
assigned program director may also serve as an NIH Project Scientist.

2.A.3. Collaborative Responsibilities

Awardee(s) agree to the governance of the study through a Steering Committee.
Steering Committee voting membership shall consist of the principal
investigators (i.e., cooperative agreement awardees), the NIH Project
Scientist, and the Chairperson. Meetings of the Steering Committee will
ordinarily be held by telephone conference call or in the metropolitan Washington
Area.

A
Data and Safety Monitoring Board will be appointed by the Director, NIH to
provide overall monitoring of interim data and safety issues; the Steering
Committee will nominate members for this Board. Meetings of the Data and Safety
Monitoring Board will ordinarily be held in Bethesda. An NIH scientist
other than the NIH Project Scientist shall serve as Executive Secretary to the
Board. An independent Protocol Review Committee, established by the NIH, will
provide peer review for each protocol. Because the Board serves as an
independent group advisory to the NIH, study investigators will not communicate
with Board members regarding study issues, except as authorized by the Board’s
Executive Secretary.

The
collaborative protocol and governance policies will call for the continued
submission of data centrally to the coordinating center for a collaborative
database; the submittal of copies of the collaborative datasets to each
principal investigator upon completion of the study; procedures for data analysis,
reporting and publication; and procedures to protect and ensure the privacy of
medical and genetic data and records of individuals. The NIH Project Scientist,
on behalf of the NIH, will have the same access, privileges and
responsibilities regarding the collaborative data as the other members of the
Steering Committee.

Each full member will have one vote. Awardee members of the Steering Committee
will be required to accept and implement policies approved by the Steering
Committee.

2.A.4.
Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within
the scope of the award) between award recipients and the NIH may be brought to
arbitration. An Arbitration Panel composed of three members will be convened.
It will have three members: a designee of the Steering Committee chosen without
NIH staff voting, one NIH designee, and a third designee with expertise in the
relevant area who is chosen by the other two; in the case of individual
disagreement, the first member may be chosen by the individual awardee. This
special arbitration procedure in no way affects the awardee's right to appeal
an adverse action that is otherwise appealable in accordance with PHS
regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

A
final progress report, invention statement, and Financial Status Report are
required when an award is relinquished when a recipient changes institutions or
when an award is terminated.

Section
VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:

Human Subjects Protection:
Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies (Phase I);
efficacy studies (Phase II); efficacy, effectiveness and comparative trials
(Phase III). Monitoring should be commensurate with risk. The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the participants
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH
is interested in advancing genome-wide association studies (GWAS) to identify
common genetic factors that influence health and disease through a centralized
GWAS data repository. For the purposes of this policy, a genome-wide
association study is defined as any study of genetic variation across the
entire human genome that is designed to identify genetic associations with
observable traits (such as blood pressure or weight), or the presence or
absence of a disease or condition. All applications, regardless of the amount
requested, proposing a genome-wide association study are expected to provide a
plan for submission of GWAS data to the NIH-designated GWAS data repository, or
provide an appropriate explanation why submission to the repository is not possible.
Data repository management (submission and access) is governed by the Policy
for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see https://grants.nih.gov/grants/gwas/

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the distribution
for an indefinite period of time. If so, the application should include a
description of the archiving plan in the study design and include information
about this in the budget justification section of the application. In addition,
applicants should think about how to structure informed consent statements and
other human subjects procedures given the potential for wider use of data
collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004, receipt date, are expected to include in the application/proposal a description
of a specific plan for sharing and distributing unique model organism research
resources generated using NIH funding or state why such sharing is restricted
or not possible. This will permit other researchers to benefit from the
resources developed with public funding. The inclusion of a model organism
sharing plan is not subject to a cost threshold in any year and is expected to
be included in all applications where the development of model organisms is
anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: (a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and (b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.

Required Education on the Protection of Human
Subject Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the
applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH
Public Access Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have
submitted for them their final, peer-reviewed manuscripts that arise from NIH
funds and are accepted for publication as of April 7, 2008, to PubMed Central (http://www.pubmedcentral.nih.gov/), to be
made publicly available no later than 12 months after publication. As of May
27, 2008, investigators must include the PubMed Central reference number when
citing an article in NIH applications, proposals, and progress reports that
fall under the policy, and was authored or co-authored by the investigator or
arose from the investigator’s NIH award. For more information, see the
Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health
Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the
Privacy Rule, including a complete Regulation Text and a set of decision tools
on "Am I a covered entity?" Information on the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, Internet
addresses (URLs) must be used for publicly accessible online
journal articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service
Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and
45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged. The
periods of career award and LRP award may overlap providing the LRP recipient
with the required commitment of time and effort, as LRP awardees must commit at
least 50 percent of their time (at least 20 hours per week based on a 40-hour week) for two years to the
research. For further information, please see: http://www.lrp.nih.gov.